Medical Futility:The Role of the Primary Care Physician
Medical Futility:The Role of the Primary Care Physician
Author: Laurence B. McCullough, PhD, Professor of Medicine and Medical Ethics, Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas.
Peer Reviewer: Eugene V. Boisaubin, MD, Professor of Medicine, University of Texas Medical Branch, Galveston, Texas.
Editor’s Note—Issues concerning clinical intervention, which is reliably judged to be futile, confront physicians in the primary and tertiary care settings. Whether the issue is something as seemingly uncomplicated as a request for antibiotics for viral respiratory infection or a demand that "everything be done" in the hospital setting for a gravely ill or dying patient, issues of futility can take their toll on physicians, members of the care team, patients, patients’ families, and health care institutions.
Every reader has a catalogue of cases in which futility has arisen in his or her own practice and institution and is well aware of the sometimes stressful and anger-provoking nature of requests for inappropriate diagnostic or therapeutic intervention. Indeed, physicians sometimes feel reduced to the role of a mere technician, or even a robot, by such requests.
Anger and stress can corrode the physician’s professional integrity and, therefore, can injure or even undermine the physician-patient relationship. Ethics provides an antidote to such stress and anger, because it provides the physician with the tools needed to think complicated and stressful issues through with the care, clarity, and considered deliberation that they require, and to reach practical, clinically applicable responses to ethical challenges in clinical practice.
The purpose of this article is to provide the reader with just such tools for thinking through ethical challenges that arise concerning issues of futility in the clinical setting. First, the reader is provided with a brief introduction to the terminology of bioethics that is particularly relevant to issues concerning futility. Second, the treatment of futility in the medical literature is reviewed. Third, the treatment of medical futility in the statements of professional associations of physicians in the United States is presented. Fourth, a policy proposal for addressing issues of futility at both the clinical and institutional levels is discussed, which has application in both the primary care and hospital settings. Fifth, the reader is provided with an overview of the first futility policy codified into advance directive legislation. Sixth, a preventive-ethics approach is described for responding effectively to the ethical challenges of futility in the clinical setting.
Introduction
Physicians have long confronted ethical challenges related to setting limits on the clinical management of patients’ problems or diagnoses. Usually these limits are set by patients (or their surrogates) in the form of noncompliance with or refusal of proffered clinical management. The ethics (and law) of informed consent provide clear guidance in these cases: the adult, competent patient has the right not to cooperate with proffered clinical management (noncompliance) and the right to refuse proffered clinical management.1 As to the latter, the patient can refuse directly, for example, by signing out of the hospital against medical advice, in which case the physician has a strict legal obligation to inform the patient about the risks that refusal creates and to document this disclosure in the chart (informed refusal). Patients can also refuse in advance, using advance directives for this purpose. These are legal instruments, whether written or oral, by which a patient can refuse treatment (typically when the patient has been diagnosed with a terminal or irreversible condition) or assign someone else to make decisions when the patient no longer has the capacity to do so. The first sort of advance directive is known variously as a living will or directive to physicians (depending on applicable law in one’s jurisdiction), and the second sort of advance directive is known variously as a durable power of attorney for health care or medical power of attorney (again, depending on applicable law).
This account of the ethics (and law) of refusing clinical management turns on the patient’s rights in the decision-making process. It would appear to stand to reason that, as a matter of logical symmetry, if patients have the right to refuse proffered clinical management, they have the right to request clinical management, as do their surrogates when the patient lacks decision-making capacity.
When patients make requests for clinical management, the issue of setting limits also arises, now from the perspective of the physician rather than from that of the patient, as in cases of refusal or noncompliance. Physicians are all too familiar with the patient with an acute viral upper respiratory infection who requests antibiotic therapy (or the parent who does so on behalf of a sick child, to avoid the cost and inconvenience of a return office visit should the infection become bacterial). Even when the physician explains that antibiotic therapy is not active against viral infection and even when the physician explains the growing concern about the overuse of antibiotics (not just in prescription form but in soaps and cleansers), the patient may renew the request. It is not unheard of for patients to say that they will just go to another physician or, if they are members of a managed care organization, will complain to the health plan’s management about the physician’s poor attitudes toward patients. Consider the patient who requests a prescription for sildenafil (Viagra) but refuses to respond to questions about his medical and sexual history, stating that it is the doctor’s job to help improve the quality of patients’ lives as the patient sees fit.
In the tertiary care setting, these issues become more challenging still. Consider the case of an 87-year-old female patient admitted to the medical intensive care unit for the management of congestive heart failure who also now has renal failure and has failed multiple attempts to be weaned from the ventilator. It is now three months into this admission and the patient is long past the average length of stay for her Medicare diagnosis-related group (DRG). Her 60-year-old daughter, who has cared for her mother in her own home for many years, insists that everything be done for her mother. When discontinuing critical care management is offered by the attending physician (who has known the patient for many years), by the critical care physician and by consultant physicians as an option that should be seriously considered, she accuses the physicians of neglecting her mother and acting solely from an interest in saving the hospital money. The reader, no doubt, has now called to mind any number of other examples from his or her own clinical experience and that of colleagues.
In short, when patients or their surrogates make requests for clinical management that the physician regards as inappropriate, the issue of setting limits arises. In the medical and bioethics literature, this issue has been addressed under the rubric of futility. How should physicians respond when patients or their surrogates request clinical management that the physician judges to be futile? The purpose of this article is to address this question in terms of response to it in the medical literature, in the statements of professional associations of physicians, in proposed institutional policy, and in recently enacted advance-directive legislation.
Terminology of Bioethics
Before turning to a discussion of the development of the topic of futility in the medical and bioethics literature, it is necessary to introduce some of the basic terminology of bioethics. Bioethics, a term coined circa 1970, describes an interdisciplinary field that studies the ethical dimensions of the health care professions, of research with simple life forms and with animal and human subjects, of the management of health care institutions such as hospitals and managed care organizations, and of health care policy.2
The focus of this article is on the first aspect of bioethics: the ethical obligations of physicians to their patients. Since the time of Hippocrates in Western medical ethics, physicians have committed themselves to the obligation of protecting and promoting the interests of their patients. There are two perspectives on those interests and how they should be protected and promoted. The first perspective is that of medicine as fiduciary profession, concerned to protect and promote the health-related interests of patients. This perspective on the general obligations of physicians is captured by the ethical principle of beneficence, which obligates the physician to seek for the patient the greater balance of clinical goods over clinical harms, as those goods and harms are identified and balanced in rigorous clinical judgment. Rigorous clinical judgment requires the discipline of science, ideally in the form of evidence to support its conclusions.3,4 (See Table 1.)
| Table 1. Two Basic Principles of Bioethics |
| • Beneficence: The physician should seek for the patient the greater balance of goods over harms, as those goods and harms are identified and balanced in rigorous clinical judgment. |
| • Respect for Autonomy: The physician should seek for the patient the greater balance of goods over harms, as those goods and harms are identified and balanced in the patient's judgment. |
The principle of beneficence was essentially the only ethical principle of medical ethics until the 19th and 20th centuries. In the 19th century, American physicians began to involve their patients in decisions about their medical care. In the 20th century, this practice was codified into the common law of informed consent.1 From this history emerged the principle of respect for autonomy in the bioethics literature since the 1970s. This principle obligates the physician to seek the greater balance of goods over harms for the patient, as those goods and harms are identified and balanced in the patient’s judgment. Patients are not required to meet standards of scientific rigor, as are beneficence-based clinical judgment and decisions.3,4 (See Table 1.)
Development of the Topic of Futility in the Medical and Bioethics Literature
The "Modicum of Benefit" Test. The topic of futility and its application to both clinical practice and institutional policy was introduced into the medical literature in a discussion of setting limits on patients’ requests in the primary care setting (see Table 2). Motivated by inappropriate requests in the primary care setting, Brett and McCullough addressed the topic in terms of "the extent to which an individual patient (having already gained access to the system) is entitled to a specific diagnostic or therapeutic measure of his or her own choosing." To analyze this issue, they distinguished between negative and positive rights, a distinction that is at the heart of the controversy surrounding futile clinical management.5
| Table 2. General Definition of Futility |
| A clinical intervention is futile in the general sense of the term when it is reliably not expected to have its usually intended effect(s). |
Negative rights are rights to be left alone—to noninterference with one’s thoughts, decisions, and actions. Normally, respecting negative rights makes few demands on our resources —we simply go about our lives as we normally do. Negative rights, therefore, are difficult to limit. The usual limit is that one’s negative rights should be respected unless doing so poses a potential for serious, far-reaching, and irreversible harm to others (e.g., a patient who refuses treatment for virulent tuberculosis and, therefore, poses a significant public health threat).
Positive rights are different. When we exercise positive rights, we lay claim to the resources of others: their time, their judgment, their decisions, and their actions. We exercise positive rights to advance what we take to be our own interests (i.e., to gain access to the resources necessary to do so). Because positive rights involve a claim on resources that we do not own (i.e., on the resources of others), all positive rights come with limits. The ethical debate is about what the limits are.
Brett and McCullough argue that when it comes to positive rights in the clinical setting, reference to the patient’s autonomy as the sole ethically relevant consideration is not adequate; both the patient’s and the physician’s perspectives on the benefits and risks of the requested intervention must be considered. When patients request unnecessary requests, such as head imaging for first-time migraine headache, or harmful interventions such an antibiotics for viral upper respiratory infections, then the physician’s autonomy—to practice medicine consistent with scientific and clinical standards of excellence (i.e., professional integrity)—is undermined.5 (See Table 4.)
In making this argument, Brett and McCullough appeal to a major principle of bioethics, beneficence.3,4 Interventions that, on such careful balancing judgment, are determined to confer no benefit or to confer net risk should not be undertaken by physicians as a matter of professional integrity. As Brett and McCullough put it, "for the patient’s anticipation of benefit to have decisive weight in the analysis, there must be at least a modicum of potential benefit, as seen from the medical perspective."5 (See Table 3.)
| Table 3. Development of the Topic of Futility in the Medical and Bioethics Literature |
| • "Modicum of benefit" test |
| • Nonbeneficial CPR |
| • Identification of four senses of "futility" |
| Table 4. Professional Integrity |
| Professional integrity is a virtue that obligates the physician to practice medicine according to standards of intellectual and moral excellence. |
Brett and McCullough go on to provide concrete clinical guidelines for setting ethically justified limits on patients’ requests for specific interventions. First, if there are no reliable, objective indications for a requested intervention, then the physician is not obligated to perform it. Second, when there is an established standard of practice in the medical community, even if it has subjective elements in it, and that standard supports a judgment that the requested intervention has no medical benefit, then there is no obligation on the part of the physician to undertake that intervention. Third, when the requested intervention is on harmful balance, the physician should not undertake it.5 Thus, the PCP should not refer an MRI for the patient who requests it for a first-time migraine headache and should not prescribe antibiotics for a viral upper respiratory infection. Why he or she is not doing so should, of course, be clearly, carefully, and compassionately explained to the patient.
Futility as Lack of Medical Benefit. In a landmark article, Blackhall extended this line of reasoning, developed for primary-care issues, to the hospital-based issue of cardiopulmonary resuscitation (CPR).6 (See Table 3.) She presented a case in which the patient was gravely ill but requested CPR, even though the team responsible for her care was opposed to performing CPR given that the patient had "leukemia unresponsive to chemotherapy, bone marrow regenerating with blasts, and lungs affected by a rapidly progressing pneumonia." Blackhall, after a review of the literature on CPR and in light of this patient’s prognosis, argued that this patient’s "chances of survival until discharge were virtually nonexistent and could not be improved with CPR."6 CPR, therefore, did not meet the criterion proposed by Brett and McCullough: it did not offer a medically "modicum of benefit" to the patient. That is, Blackhall appeals to a beneficence-based concept of medical futility, now applied in the hospital setting.
Blackhall correctly notes in her discussion of this case that the issue was not just the request by the patient and her family that she receives full support, including CPR. A more basic ethical problem was that this patient was offered such support in the first place. Doing so was inconsistent with reliable, beneficence-based clinical judgment and offered the patient and her family only the "cruel hope" that led them to make decisions that were bound only to increase the patient’s suffering.
The ethics of informed consent come to bear at this point in Blackhall’s argument. In the informed consent process, the physician is obligated only to offer clinical alternatives that are medically reasonable (i.e., that are reliably expected to confer at least a modicum of benefit to the patient).1 In particular, when a primary care treatment or more advanced treatment such as CPR is judged on the basis of available, relevant evidence or accepted standards of practice to be of no medical benefit to the patient, then it should not be offered. Thus, this landmark article initiated a discussion of the ethics of futility and its use in refusing to comply with patients’ inappropriate requests and in identifying which available alternatives are medically reasonable in terms of expected medical benefit.
Further Refinement of the Concept of Futility. Blackhall’s argument defined futility in rather global terms. Subsequent literature undertook the task of refining the concept by identifying different senses or clinical categories of futility and focused almost exclusively on hospital-based issues (see Table 3).
Tomlinson and Brody introduced an account of futility based on expected quality of life after CPR.7 They argued that, when expected quality of life would be such that the patient would not accept it, then CPR should be regarded as futile. That is, CPR might have medical benefit in the form of extending the patient’s life but the loss of functional status would result in a quality of life that, before resuscitation, would be "minimally acceptable" but would not be after CPR. They also argued that when the patient’s current quality of life is unacceptable to the patient, then CPR should be regarded as futile.7 Tomlinson and Brody are appealing to futility in terms of interventions that are not reliably expected to achieve their goals, in this case, as those goals are defined by the patient for himself or herself. While they agree that patients’ values are not relevant to the sort of strictly medical judgment of lack of benefit to the patient (e.g., in terms of survival), they claim that patients’ values are directly relevant to judgments of futility based on the patient’s quality of life before or after CPR. Thus, in addition to Blackhall’s beneficence-based concept of medical futility, Tomlinson and Brody introduce the autonomy-based concept of quality-of-life futility.
In a subsequent article, Tomlinson and Brody make a crucial addition to Blackhall’s argument about futility.8 Blackhall had appealed to the physician’s autonomy in making her case that judgments of lack of medical benefit should be decisive in offering and performing CPR.6 Tomlinson and Brody explain that the integrity of medicine as a profession is at stake. They argue that, if the claim is just that the individual physician should have his or her autonomy respected, then there is no particular reason to give preference to that autonomy over the autonomy of the patient. Rather, medicine as a profession should be accorded some autonomy over the power that it wields over patients. Respect for the autonomy of the medical profession presumes that members of that profession will use their power to benefit and not to harm patients (i.e., that physicians will guide the use of their power over patients by beneficence-based clinical judgment and decision making). Furthermore, developing another aspect of Blackhall’s argument, they argue that offering medically futile interventions undermines patient autonomy. The physician who offers medically futile intervention, they argue, sends a "mixed message" to the patient who expects physicians to offer interventions because they offer the probability of benefiting the patient.8
Strict and Overall Futility. Schneiderman, Jecker, and Jonsen made a significant contribution to the understanding and clinical applicability of appeals to futility by distinguishing different beneficence-based senses of the term. Futility in the clinical setting does have the meaning of an intervention not being reliably expected to have its expected effect. This is the sense of futility used by Blackhall when she argued that there are some diagnoses in which CPR will not achieve the effect of the patient continuing to live to discharge. Schneiderman, Jecker, and Jonsen accept this sense of futility but argue that it is not sufficient to address the full range of clinical cases in which concerns about futility justifiably arise.9,10
Therefore, Schneiderman, Jecker, and Jonsen identify a second sense of futility—not benefiting the patient as a whole. In these cases, the clinical intervention may achieve its intended physiologic effect but does not improve the "person as a whole." In particular, if an intervention results only in maintaining a patient in a state of permanent unconsciousness or in a state in which the patient is irreversibly dependent on critical care, then the intervention should also be judged to be futile.
Brody and Halevy distinguish four different types of futility judgments.11 The first is strict or physiologic futility. The second is what they call "imminent demise futility," the reliable expectation that the patient will die before discharge no matter what is done. This is the sense of futility that plays a large role in Blackhall’s views.6 The third is "lethal futility" (i.e., the patient’s condition is not compatible with long-term survival, although the patient might survive to discharge). The fourth is "qualitative futility," based on the judgment that the resultant quality of life of the patient is so poor that further intervention is not ethically justified.11 This is similar to Tomlinson and Brody’s concept of qualitative futility.8,9
Four Senses of "Futility." While there has yet to emerge a standard nomenclature in these matters, we can summarize the preceding account of the development of the topic of futility in the medical and bioethics literature in terms of three beneficence-based concepts of futility and one autonomy-based concept of futility (see Table 5).
| Table 5. Four Senses of Futility |
| Beneficence-Based Senses |
| • Strict futility |
| • Clinical futility |
| • Imminent demise futility |
| Autonomy-Based Sense |
| • Qualitative futility |
The first two beneficence-based concepts of futility developed by Schneiderman, Jecker, and Jonsen are strict or physiologic futility and clinical futility. When a clinical intervention is reliably judged not to be expected to produce its intended physiologic effect (e.g., killing bacteria or maintaining cardiopulmonary function), then it is strictly or physiologically futile. When a clinical intervention results in the patient being unable to relate to the environment and in continuing to develop as a human being, then it is clinically futile. This sense of futility is also captured by Brody and Halevy’s category of lethal condition futility. The third beneficence-based sense of futility is Brody and Halevy’s category of imminent demise futility.
To these three senses, we can add a fourth autonomy-based concept from the work of Tomlinson and Brody—qualitative futility. This sense of futility also draws on Brody and Halevy’s category of qualitative futility. An intervention is futile in this sense when it will maintain a quality of life that is unacceptable to the patient or is reliably expected to result in a quality of life that is unacceptable to the patient. It must be emphasized that this concept of futility does not appeal to the beneficence-based clinical judgment of physicians about acceptable quality of life or to the judgments of the patient’s family about acceptable quality of life. These "external" judgments about quality of life are fraught with difficulty, especially given the evidence that quality-of-life ratings by observers of patients with significant functional loss are systematically lower than the quality-of-life judgments of these patients.12 Quality-of-life futility judgments are, therefore, only autonomy-based and never acceptable when beneficence-based. This is because quality-of-life judgments about futility cannot be made with the intellectual rigor required of beneficence-based clinical judgments.
Development of the Topic of Futility in the Statements of Professional Associations of Physicians
Statements on ethical issues in clinical practice and research constitute an important genre of the medical and bioethics literature. This literature has, however, been difficult to access, a problem now remedied by the publication of the first comprehensive collection of the states and codes of ethics of professional associations of physicians in the United States.13 This genre of bioethics literature has a long pedigree, dating back to the first national code of medical ethics in the modern world, the Code of Ethics of the American Medical Association (AMA) of 1847.14
Several professional physicians’ associations have addressed the topic of futility. The views of these associations go beyond the analyses and proposals of individual authors to present the considered judgments of the ethics committees of these associations. These statements can be read as important and relevant guidelines that should be given serious consideration by clinicians in practice. While the focus in these statements tends to be on hospital-based issues, reflecting the dominance of these in the literature, they do have application in primary care, as well.
The American Medical Association (AMA). The AMA issues statements on ethics through its Council on Ethical and Judicial Affairs. The AMA states that physicians "are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients." This appeals to a general, beneficence-based definition of futility and claims that there is no ethical obligation on the part of physicians to provide medical care simply on the basis of the patient’s request or demand for it. Because "the concept of futility’. . . cannot be meaningfully defined," the physician’s decisions not to intervene should be based on the AMA’s guidelines for allocating resources and for providing adequate patient care.15
The AMA’s guidelines for allocating resources point out that allocation decisions should be based on "ethically appropriate criteria relating to medical need," which include "likelihood of benefit" but do not include nonmedical considerations such as "ability to pay, age, social worth, perceived obstacles to treatment, patient contribution to illness, or past use of resources."15 That is, resource-allocation decisions should be exclusively beneficence-based.
This beneficence-based approach becomes apparent in the AMA’s guidelines for adequate patient care. Clinical judgments of adequacy should be guided by the following considerations:
1) degree of benefit (the difference in outcome between treatment and nontreatment; 2) likelihood of benefit; 3) duration of benefit; 4) cost; and 5) number of people who will benefit (referring to the fact that a treatment may benefit the patient and others who come into contact with the patient, as with a vaccination or antimicrobial drug).15
The AMA underscores the importance of institutional policy in this area by calling on institutions to create a just and open process that should be followed by physicians and institutional entities, such as ethics committees, in reaching judgments about futility based on allocation of resources and adequacy of clinical management.
The AMA statements can be read as basing clinical judgments of futility on beneficence. The AMA provides a general conceptual framework for making clinical judgments of futility, but it does not go into the level of detail of identifying the different senses of futility and their application in clinical judgment that we found in the above review of the medical and bioethics literature.
American College of Physicians (ACP). The ACP provides a general account of futile interventions. "In the unusual circumstance that no evidence shows that a specific treatment will provide any benefit from any perspective, the physician need not provide such treatment." This is a stricter definition of futility than that proposed by the AMA. While the physician is under no obligation to "provide an effort at resuscitation that cannot conceivably restore circulation and breathing, the physician should help the family to understand and accept this position."16 The patient or surrogate, as appropriate, must be informed about unilateral do-not-resuscitate (DNR) orders.
Society of Critical Care Medicine (SCCM). The SCCM takes the general position that the physician has no ethical obligation to "offer, begin, or maintain a treatment, which, in his or her best judgment, will be physiologically futile." In another statement, the SCCM defines futile interventions as those that "will not accomplish their goal." The SCCM identifies four classes of intervention: "a) treatments that have no beneficial physiologic effect; b) treatments that are extremely unlikely to be beneficial; c) treatments that have beneficial effect but are extremely costly; and d) treatments that are of uncertain or controversial benefit." Because of the diverse value judgments that define other forms of treatment with limited benefit, "any policy to limit nonfutile treatment should be developed with the participation of all interested parties."17
In treatments that are physiologically futile, class "a" "should never be offered." Those treatments in which benefit is uncertain or unlikely, classes "b" and "d" should not be called futile but rather labeled "inadvisable." Treatments that have benefit but are extremely costly (class "c") "should be governed by principles of distributive justice." The SCCM proposes criteria for development of policies about futile and about inadvisable treatment.17 Class "a" parallels the concept of strict or physiologic futility, while class "b" parallels the concept of clinical futility. The SCCM wisely points out that issues of economic cost should not enter judgments of futility, repeating the position of the AMA.
American College of Emergency Physicians (ACEP). The ACEP endorses a role for clinical judgments of futility in emergency medicine.
What is the significance of this debate about futility and decision-making authority? Emergency physicians do make decisions to cease resuscitative efforts or not initiate efforts in medically hopeless circumstances. These are properly medical decisions that should not require family consent.18
Judgments about clinical futility should not include considerations of quality of life. Presumably, this includes both autonomy-based and beneficence-based quality-of-life judgments, but the ACEP does not make this distinction, which is made in the medical and bioethics literature on futility.
In a later statement, the ACEP adds the following:
"Resuscitation efforts should be limited based on patient direction or a medically sound determination of futility. Scientific investigation must continue in order to define those circumstances when resuscitations will be futile."19
Therefore, the ACEP accepts judgments of futility in cases that are "hopeless." That is, when emergency interventions are strictly or physiologically futile (e.g., because no patient is expected to survive), then such interventions can be discontinued or withheld.
Proposed Model Institutional Policy
Given the several senses of the concept of futility discussed above and the obvious need for institutional policy to support clinical judgment and decision making in this delicate and controversial area, it is important for physicians who invoke any one of the four senses of futility identified above to have institutional backing for their clinical judgments and recommendations to patients or patients’ families based on those clinical judgments. Responding to this need, Halevy and Brody organized a task force representing the ethics committees of Houston to develop a model institutional policy on medical futility.20 (See Table 6.)
| Table 6. Model Institutional Policy on Medical Futility |
| • Explain rationale for judgment of medical futility. |
| • Offer option of transfer and provide copy of institutional policy. |
| • Make additional resources available to patient/surrogate. |
| • Obtain second opinion and ethics committee review. |
| • Provide notice of ethics committee meeting to patient/surrogate. |
| • Encourage participation in ethics committee process. |
| • If committee supports physician, then intervention may be discontinued. If committee does not support physician, intervention may be discontinued only with consent of patient/surrogate. |
| • If committee supports physician, intrainstitutional transfer is allowed, but only for palliative/hospice care. |
| • Procedures for medical futility may be initiated only by the physician. |
This policy is distinctive in that it emphasizes a process-based approach to take account of the different senses of futility. This approach requires the involvement of patients or their surrogates throughout the process. In addition, the proposed policy does not permit physicians to act unilaterally on their futility judgments, as some have proposed they should do, but the policy requires several layers of review in order to bring such judgments to a high level of clinical and ethical discipline. This proposed policy preserves the patient’s right to be transferred to another physician or facility that would be willing to provide intervention that the attending physician judges to be inappropriate. Fourth, and crucially, the policy requires appropriate end-of-life care when life-prolonging treatment is withdrawn as inappropriate, so that patients are not abandoned in their last days and hours.20
The procedures steps set out in this model of institutional policy are the following:
1. When the physician reaches the judgment that clinical intervention is not appropriate, then he or she should explain the rationale for this judgment and also explain that the patient will not be abandoned.
2. The physician should explain the option of transfer and provide the patient or patient’s surrogate with a copy of the institution’s guidelines on futile/inappropriate clinical management.
3. Additional institutional resources, such as ethics consultation, should be made available to the patient or the patient’s surrogate.
4. If an agreement cannot be reached, then the physician must obtain a second opinion from a colleague who has examined the patient, as a way to review the care and discipline with which the physician has reached the judgment that intervention is inappropriate/futile. In addition, the case must be reviewed by a designated institutional committee (e.g., the hospital ethics committee).
5. The patient or surrogate must be given 72-hour notice of the meeting of this review committee and information about its possible outcomes.
6. The physician and patient/surrogate should be encouraged to participate in the review process set out in step no. 4.
7. If the committee supports the physician’s judgment that intervention is inappropriate, then that intervention may be discontinued and replaced with comfort and palliative care. If the committee does not support the physician, orders to limit intervention will not be considered valid without the consent of the patient/surrogate.
8. If the committee supports the physician, intrainstitutional transfers will be allowed, but not for the purpose of administering intervention that the committee has judged to be inappropriate.
9. The procedures identified in the policy may be initiated only by the physician. Concern on the part of other health care professionals, family members, etc., should be addressed through existing mechanisms, such as ethics consultation.20
The advantage of this step-wise policy is that it will result in rigorous and well-founded judgments of futility. The required reviews by a colleague and then by a committee should ensure that the relevant senses of futility are clearly identified and tested for their clinical validity. The required committee review also provides an opportunity for family members to express their views and have them taken serious by an institutional committee. Finally, if the committee supports the physician, then he or she will know that the institution sanctions this support, because it was issued from an approved institutional policy.
This policy proposal is intended mainly to address hospital-based requests for inappropriate clinical management. However, its first two steps apply directly to the primary care setting. Consider the requested antibiotics for a viral infection. The PCP should explain in what sense the intervention is futile (i.e., strict or physiologic futility). Ideally, there should be an organizational guideline that supports this judgment, so that, in explaining the option for a second opinion, the physician can explain that his or her colleague will follow the same guideline. PCPs should take full advantage of the shift to group practice and to managed care and develop such guidelines and implement them uniformly. Doing so will help to prevent the "doctor shopping" strategy that patients often use, or threaten to use, to have their inappropriate requests implemented.
Futility Policy in Advance Directive Legislation
In its 1999 session, the Texas State Legislature consolidated into one piece of legislation existing statutes on living wills, durable power of attorney for health care, and out-of-hospital DNR orders.21 In the process of doing so, the Legislature took the quite reasonable view that, if an advance directive can be used to refuse intervention (as the living will had been used to do), then, because this right is based on a general right to make health care decisions, an advance directive can be used to request intervention. The Legislature also recognized that, in codifying a right to request intervention, it would be necessary to place limits on that right, out of respect for the integrity of the medical profession. Therefore, the Legislature made a provision for how the physician and institution should respond when the physician is not willing to carry out a directive that requests intervention or that "everything be done." This provision of the law has come to be known informally as its "futility policy."
The new statute first requires that treatment will continue during the process of review required by the law. The law requires that the physician’s refusal to implement a directive "shall be reviewed by an ethics or medical committee" of the institution. The patient or surrogate shall also be provided with at least 48-hours notice of the meeting of this committee and is entitled to attend it. At the conclusion of the meeting, the patient/surrogate shall be provided a written report of the committee’s decision and this report shall be included in the patient’s record.
If the physician does not agree with the committee’s decision, he or she shall make a reasonable effort to transfer the patient to another physician who would be willing to implement the committee’s decision. The institution is required to assist in this effort.
If the committee supports the physician’s judgment that continued "life-sustaining treatment" is "inappropriate" (the terminology used in the statute), then such treatment shall continue to be administered for a 10-day period. During this time, the patient/surrogate is free to seek transfer to another facility. At the end of the 10-day period, the physician and institution may discontinue the life-sustaining treatment unless the patient/surrogate has been successful in arranging a transfer or has obtained a court order to continue such treatment. Such an order shall be issued by the appropriate court of jurisdiction "only if the court finds, by a preponderance of the evidence, that there is a reasonable expectation" that there is another physician (or facility) who will accept the patient on transfer. This provision contemplates both intrainstitutional and interinstitutional transfer. The statute, as is typical of advance-directive legislation, grants both civil and criminal immunity for physicians, health care professionals, and institutions that withdraw life-sustaining treatment from patients under the provisions of the statutes. As the reader can see, many of the proposals of Brody and Halevy in their model institutional policy for medical futility were codified into this statute.
This statute became effective on September 1, 1999. Since that time, there have been anecdotal reports of the implementation of its "futility policy" in case of adult as well as pediatric patients. These cases, however, have yet to be reported in the medical literature at the present time. It is worth noting that these legislative changes had the support of the right-to-life community in Texas, indicating the broad support that exists for them.
A Preventive Ethics Approach to Futility Judgments in the Clinical Setting
The medical literature, the statements of professional associations of physicians, and law provide considerable guidance to physicians concerning futility and its application in clinical judgment and practice. Physicians should take a preventive ethics approach to the topic of medical futility in both the primary care and hospital settings. Clinical experience teaches that it is preferable to prevent ethical conflict, not to mention interpersonal conflict and suspicion, that can arise when patients or their surrogates make inappropriate requests for prescriptions or referrals in the office of that "everything be done" in the hospital setting, when the physician or other members of the health care team reliably judge such intervention to be inappropriate because it is futile in one of the senses described. Indeed, failure to adopt a preventive ethics strategy in response to requests for futile clinical management usually makes things worse, rather than better (see Table 7).
| Table 7. Preventive Ethics |
| • Identify built-in potential for ethical conflict in clinical practice and in organizational practice and policy. |
| • Identify strategies for preventing conflicts from occurring. |
| • Manage well the conflicts that do, nonetheless, occur. |
Recently, Doukas and McCullough described a preventive ethics approach to counseling patients about futility in the primary care setting. They emphasize that discussions about futility should not be postponed until the hospital setting, when they are likely to be more rushed and pressured. They also describe two basic preventive-ethics strategies: explanation of and recommendation against futile interventions; and negotiated response to requests for futile interventions.22
Doukas and McCullough describe five steps for implementing these two strategies (see Table 8).
| Table 8. A Preventive Ethics Approach to Futility Judgments in the Clinical Setting |
| • Explore the patient's/surrogate's reasoning behind request for futile intervention(s). |
| • Negotiate differences. |
| • Attempt respectful persuasion. |
| • Undertake trial of continuing intervention, but with negotiated stopping rules based on one or more senses of futility. |
| • Seek review by an institutional ethics committee, consistent with institutional policy and applicable law. |
1. When patients or their surrogates make requests for inappropriate or futile interventions, explore the patient’s or surrogate’s reasoning with him or her. The physician should be attentive to and correct false beliefs or unrealistic expectations that the patient or surrogate may have. The physician should also elicit the patient’s or surrogate’s values and explore how the alternative of nonintervention might also support those values.
2 If this step fails to persuade the patient or surrogate, then the physician should negotiate differences. The physician should emphasize that professional integrity justifiably sets limits on requests for futile intervention. The physician should then explain his or her reasoning for the clinical judgment of futility, especially the available evidence that supports this clinical judgment. The physician should explain precisely in which of the four senses of futility he or she judges continuing or initiating intervention to be futile. This clinical judgment should meet the standards of adequacy prescribed by the AMA. It should be made clear to the patient/surrogate that there is not reference or appeal to economic costs in the clinical judgment of futility.
3. If agreement cannot be reached, attempt what is called respectful persuasion: pointing out how nonintervention supports the patient’s values.23 In particular, when the iatrogenic risk of continuing intervention is beginning to mount, the physician should explore with the patient/surrogate the patient’s views on quality of life and how these values may be threatened by continued intervention, an invocation of qualitative futility.
4. If respectful persuasion fails, undertake a trial of continuing intervention, but with negotiated stopping rules based on one or more of the four senses of futility and consistent with institutional policy and applicable law. This step gives the patient/surrogate a level of control over the decision but not complete control. Granting this level of control may be enough, by itself, to defuse conflict. This step also requires the patient/surrogate to take seriously the physician’s judgment that the intervention does not meet the basic test of conferring a modicum of benefit on the patient.
5. If this step fails, seek review by an institutional ethics committee, consistent with institutional policy and applicable law. In doing so, the physician should be prepared to identify which sense of futility is relevant to the evaluation of the intervention in question and what evidence and other clinical information supports such a judgment. Here the statements of the professional associations of physicians, the model policy proposed by Brody and Halevy, and the new Texas statute on advance directives provide considerable guidance.
Note the underlying concern of this approach—the physician-patient relationship should be preserved. Family members and their concerns should be heard and taken seriously. These two crucial values can be more effectively supported and implemented in the lower-stress environment of the outpatient setting than they can in the higher-stress hospital setting. Just as important, patients and their family members should be willing to listen to and take seriously the scientific, clinical, and ethical concerns of the physician, the health care team, and the institution out of respect for professional integrity. There is more time to address such concerns in the primary care than hospital setting. Therefore, PCPs should take a vigorous preventive ethics approach to futility in their practices.
References
1. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York, NY: Oxford University Press; 1986.
2. Reich WT. Introduction. In: Reich WT, ed. Encyclopedia of Bioethics. 2nd ed. New York, NY: Macmillan; 1995:xix-xxxii.
3. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994.
4. Beauchamp TL, McCullough LB. Medical Ethics: The Moral Responsibilities of Physicians. Englewood Cliffs, NJ: Prentice-Hall, Inc.; 1984.
5. Brett AS, McCullough LB. When patients request specific interventions: Defining the limits of the physician’s obligations. N Engl J Med 1986;315:1347-1351.
6. Blackhall LJ. Must we always use CPR? N Engl J Med 1987; 317:1281-1285.
7. Tomlinson T, Brody H. Ethics and communication in do-not-resuscitate orders. N Engl J Med 1988;318:43-46.
8. Tomlinson T, Brody H. Futility and the ethics of resuscitation. JAMA 1990;264:1276-1280.
9. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: Its meaning and ethics implications. Ann Intern Med 1990; 112:949-954.
10. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: Response to critiques. Ann Intern Med 1990;125:669-674.
11. Brody BA, Halevy A. Is futility a futile concept? J Med Philos 1995;20:123-144.
12. Leplege A, Hunt S. The problem of quality of life in medicine. JAMA 1997;278:47-50.
13. Brody BA, Rothstein MA, McCullough LB, Bobinski MA. Medical Ethics: Codes, Opinions, and Statements. Washington, DC: Bureau of National Affairs; 2000.
14. Baker RB, Caplan AL, Emanuel LL, Latham SR, eds. The American Medical Ethics Revolution: How the AMA’s Code of Ethics Has Transformed Physicians’ Relationships to Patients, Professionals, and Society. Baltimore, Md: Johns Hopkins University Press; 1999.
15. American Medical Association, Council on Ethical and Judicial Affairs. Code of Medical Ethics: Current Opinions, 1998-1999 edition. Chicago, Ill: American Medical Association; 1999. In: Brody BA, Rothstein MA, McCullough LB, Bobinski MA. Medical Ethics: Codes, Opinions, and Statements. Washington, DC: Bureau of National Affairs; 2000:5-57.
16. American College of Physicians. Ethics Manual, 4th ed. Ann Intern Med 1998;128:576-594. In: Brody BA, Rothstein MA, McCullough LB, Bobinski MA. Medical Ethics: Codes, Opinions, and Statements. Washington, DC: Bureau of National Affairs; 2000:745-761.
17. Ethics Committee, Society of Critical Care Medicine. Consensus statement of the Society of Critical Care Medicine Ethics’ Committee regarding futile and other possibly inadvisable treatments. Crit Care Med 1997;25:387-391. Brody BA, Rothstein MA, McCullough LB, Bobinski MA. Medical Ethics: Codes, Opinions, and Statements. Washington, DC: Bureau of National Affairs; 2000:179-183.
18. American College of Emergency Physicians. Ethical issues for resuscitation. Brody BA, Rothstein MA, McCullough LB, Bobinski MA. Medical Ethics: Codes, Opinions, and Statements. Washington, DC: Bureau of National Affairs; 2000:230-234.
19. American College of Emergency Physicians. Policy summaries. Brody BA, Rothstein MA, McCullough LB, Bobinski MA. Medical Ethics: Codes, Opinions, and Statements. Washington, DC: Bureau of National Affairs; 2000:225-229.
20. Halevy A, Brody BA. A multi-institution collaborative policy on medical futility. JAMA 1996;276:571-574.
21. Texas Advance Directives Act. Senate Bill 1260. 76th Session. Available at: http://www.capitol.state.tx.us/.
22. Doukas DJ, McCullough LB. A preventive-ethics approach to counseling patients about futility in the primary care setting. Arch Fam Med 1996;5:589-592.
23. McCullough LB, Chervenak FA. Ethics in Obstetrics and Gynecology. New York, NY: Oxford University Press; 1994.
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